DRAP plans post marketing surveillance of drugs
Unveils system of vigilance for pharmaceutical companies
Unveils system of vigilance for pharmaceutical companies. PHOTO: REUTERS
ISLAMABAD:
The federal drug regulator is set to introduce new regulations drafted for pharmaco-vigilance (PV) and post marketing activities (PMS) of drugs in Pakistan - a big tool to identify unsafe, fake, counterfeit drugs - in line with international practices to ensure safety of population.
The Drug Regulatory Authority of Pakistan (DRAP) in collaboration with USP-PQM organised a central and interprovincial consultative meeting on August 17-18 in Islamabad, on PMS of drugs and PV drug safety reporting.
Senior officials from provincial government’s health department, Gilgit Baltistan, and ICT participated in the meeting and devised a framework for development of PVS.
DRAP CEO Dr M Aslam highlighted features of the new regulation drafted for PV and PMS in line with international practices to ensure safety of population.
“We need to spread awareness through educational campaigns, institutional visits, trainings, workshops and using technical support from WHO and USP-PQM, a country-wide culture will be developed for its reporting system with a positive mindset for larger interest of patients,” the CEO said.
PMS is a big tool to identify unsafe, fake, counterfeit drugs through PV reporting and can strengthen our campaign against spurious, fake and counterfeit drugs, he said.
He added that, DRAP, as part of PV activity, has already introduced new Adverse Drugs Reaction (ADR) reporting system and posted ADR forms on its website for both healthcare professionals and Pharma Industry.
DRAP is also introducing bio-study rules and code of ethics for pharmaceutical companies’ interaction with medical professionals, which are under active process.
DRAP is developing a national PV centre in coordination with provinces which will develop their own vigilance centres. DRAP is going for the membership of WHO Uppsala centre for access to ‘Vigiflow’, its global database system for PV reporting and this access will support regulators and medical professionals with latest safety information about the drugs, in the larger patient interest.
DRAP Pharmacy Services Director Sheikh Ansar updated the participants that more than 80 companies are regularly submitting the ADR reports of their products, on a monthly basis. National PV Centre will also perform assessment and risk analysis of those ADRs by a scientific advisory committee.
Linkage with WHO Uppsala centre will improve information system for the safety of the local patients. Provincial representatives also presented their existing healthcare structure and future plans for improvement in the system.
Senior international pharmacy consultant Sultan Ghani said the government has introduced harmonised PV system across the country. He said all healthcare professionals, physicians, pharmacists, nurses and paramedics and pharmaceutical industry are part of this vigilance system of the pharmaceutical sector.
“We need to develop a culture of ADR among professionals in Pakistan,” he said.
Ghani emphasised on performing scientific assessment and risk analysis of ADR and then to take a centralised regulatory steps. Meeting participants drafted a framework for regulations and guidelines for PV, along with additional expert advice for further improvement.
Published in The Express Tribune, August 21st, 2017.
The federal drug regulator is set to introduce new regulations drafted for pharmaco-vigilance (PV) and post marketing activities (PMS) of drugs in Pakistan - a big tool to identify unsafe, fake, counterfeit drugs - in line with international practices to ensure safety of population.
The Drug Regulatory Authority of Pakistan (DRAP) in collaboration with USP-PQM organised a central and interprovincial consultative meeting on August 17-18 in Islamabad, on PMS of drugs and PV drug safety reporting.
Senior officials from provincial government’s health department, Gilgit Baltistan, and ICT participated in the meeting and devised a framework for development of PVS.
DRAP CEO Dr M Aslam highlighted features of the new regulation drafted for PV and PMS in line with international practices to ensure safety of population.
“We need to spread awareness through educational campaigns, institutional visits, trainings, workshops and using technical support from WHO and USP-PQM, a country-wide culture will be developed for its reporting system with a positive mindset for larger interest of patients,” the CEO said.
PMS is a big tool to identify unsafe, fake, counterfeit drugs through PV reporting and can strengthen our campaign against spurious, fake and counterfeit drugs, he said.
He added that, DRAP, as part of PV activity, has already introduced new Adverse Drugs Reaction (ADR) reporting system and posted ADR forms on its website for both healthcare professionals and Pharma Industry.
DRAP is also introducing bio-study rules and code of ethics for pharmaceutical companies’ interaction with medical professionals, which are under active process.
DRAP is developing a national PV centre in coordination with provinces which will develop their own vigilance centres. DRAP is going for the membership of WHO Uppsala centre for access to ‘Vigiflow’, its global database system for PV reporting and this access will support regulators and medical professionals with latest safety information about the drugs, in the larger patient interest.
DRAP Pharmacy Services Director Sheikh Ansar updated the participants that more than 80 companies are regularly submitting the ADR reports of their products, on a monthly basis. National PV Centre will also perform assessment and risk analysis of those ADRs by a scientific advisory committee.
Linkage with WHO Uppsala centre will improve information system for the safety of the local patients. Provincial representatives also presented their existing healthcare structure and future plans for improvement in the system.
Senior international pharmacy consultant Sultan Ghani said the government has introduced harmonised PV system across the country. He said all healthcare professionals, physicians, pharmacists, nurses and paramedics and pharmaceutical industry are part of this vigilance system of the pharmaceutical sector.
“We need to develop a culture of ADR among professionals in Pakistan,” he said.
Ghani emphasised on performing scientific assessment and risk analysis of ADR and then to take a centralised regulatory steps. Meeting participants drafted a framework for regulations and guidelines for PV, along with additional expert advice for further improvement.
Published in The Express Tribune, August 21st, 2017.